510(k) · Cleared
Recalled · Class II · 2021Vented/Non-Vented Gemini Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imed Corp. · FPA Set, Administration, Intravascular
Cleared on Feb 14, 1995 after a 169-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 14, 1995
- Review
- 169 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 7
- Predicates
- 0
5 later devices descend from it, 5 citing it directly.
- This deviceK944320 Vented/Non-Vented Gemini Administration SetImed Corp. · 1995
- Descendant · cites it directly · 1 of its ownK955821 I.V. Administration SetsMedical Associates Network, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK971500 Access Systems Needleless Vial AdapterBiological & Environmental Control Laboratories · 1997
- Descendant · cites it directly · 0 of its ownK962801 Safe Mate I.V. Extension SetsBiological & Environmental Control Laboratories · 1996
- Descendant · cites it directly · 0 of its ownK962802 Safe Mate I.V. Fluid Delivery SetsBiological & Environmental Control Laboratories · 1996
- Descendant · cites it directly · 0 of its ownK961327 Bec Needleless Injection SiteBiological & Environmental Control Laboratories · 1996
Most influential descendants
Showing 5 of 5 · See all- K955821I.V. Administration SetsMedical Associates Network, Inc. · 1996 · cites it directly1descendant
- K971500Access Systems Needleless Vial AdapterBiological & Environmental Control Laboratories · 1997 · cites it directly0descendants
- K962801Safe Mate I.V. Extension SetsBiological & Environmental Control Laboratories · 1996 · cites it directly0descendants
- K962802Safe Mate I.V. Fluid Delivery SetsBiological & Environmental Control Laboratories · 1996 · cites it directly0descendants
- K961327Bec Needleless Injection SiteBiological & Environmental Control Laboratories · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944320 | Vented/Non-Vented Gemini Administration Set | Imed Corp. | 1995 | — |
| +1 | K955821 | I.V. Administration Sets | Medical Associates Network, Inc. | 1996 | — |
| +1 | K971500 | Access Systems Needleless Vial Adapter | Biological & Environmental Control Laboratories | 1997 | — |
| +1 | K962801 | Safe Mate I.V. Extension Sets | Biological & Environmental Control Laboratories | 1996 | — |
| +1 | K962802 | Safe Mate I.V. Fluid Delivery Sets | Biological & Environmental Control Laboratories | 1996 | — |
| +1 | K961327 | Bec Needleless Injection Site | Biological & Environmental Control Laboratories | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2021 | Class II | Z-2459-2021 | Process control | Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not… |
| Feb 15, 2016 | Class II | Z-1179-2016 | Other | CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set. |
| Nov 5, 2015 | Class II | Z-0445-2016 | Other | CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion. |
| Jun 17, 2014 | Class II | Z-2025-2014 | Labeling Change Control | CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it… |
| Nov 8, 2013 | Class II | Z-0435-2014 | Employee error | CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended. |
| Nov 8, 2013 | Class II | Z-0450-2014 | Employee error | CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing. |
| Aug 30, 2013 | Class II | Z-2285-2013 | Process design | CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K955821 (Medical Associates Network, Inc., 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
https://510kreport.com/device/K944320 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944320: Vented/Non-Vented Gemini Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944320
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026